Long-acting Naltrexone for Pre-release Prisoners

Description

This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.

Conditions

Opiate Addiction

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Study Overview

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Study Details

Study overview

This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.

Long-acting Naltrexone for Pre-release Prisoners: A Randomized Trial of Mobile Treatment

Long-acting Naltrexone for Pre-release Prisoners

Condition
Opiate Addiction
Intervention / Treatment

-

Contacts and Locations

Towson

Maryland Department of Public Safety and Correctional Services, Towson, Maryland, United States, 21286

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days
  • * History of opiate disorder \[meeting DSM-V criteria of dependence at the time of incarceration\]
  • * Suitability for XR-NTX treatment as determined by medical evaluation
  • * Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal
  • * Willingness to enroll in XR-NTX treatment in prison \[not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release\]
  • * Planning to live in Baltimore City or County.
  • * Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration
  • * Liver function test levels greater than three times normal
  • * Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable
  • * Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed
  • * History of allergic reaction to XR-NTX
  • * Current chronic pain diagnosis for which opioids are prescribed
  • * Creatinine above normal limits
  • * Pregnancy (for women)
  • * Breast-feeding (for women)
  • * Suicidal ideation (within the past 6-months)
  • * Body Mass Index (BMI) \> 40
  • * Unadjudicated charges that may result in transfer to another facility and/or additional prison time.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Friends Research Institute, Inc.,

Michael S Gordon, DPA, PRINCIPAL_INVESTIGATOR, Friends Research Institute, Inc.

Study Record Dates

2025-06-01